BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3851383 · Received June 5, 2014

    Report

    Report Number
    3005168196-2014-00365
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PET-LOCK IS STILL INTACT ON THE PROXIMAL END OF THE PUSHER WIRE. THE PULL WIRE IS STILL LOCATED INSIDE THE CAPTURE FEATURE OF THE DISTAL DETACHMENT TIP (DDT). THE COIL IS DETACHED FROM THE PUSHER. THE PROXIMAL CONSTRAINT BALL IS STILL ATTACHED TO THE COIL. THE STRETCH RESISTANT (SR) WIRE IS FRACTURED. CONCLUSION: THE COMPLIANT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL WAS ADVANCED AND RETRACTED A FEW TIMES THEN IT DETACHED. EVALUATION OF THE RETURNED DEVICE CONFIRMED AN UNINTENTIONAL DETACHMENT OF THE COIL AS EVIDENCED BY THE INTACT PET-LOCK ON THE PROXIMAL END OF THE PUSHER, INDICATING THE COIL WAS NOT DETACHED WITH THE DETACHMENT HANDLE OR MANUALLY DETACHED BY BREAKING THE HYPOTUBE. IT APPEARS THAT DURING MANIPULATION OF THE COIL, FORCE IN EXCESS OF THE TENSILE STRENGTH OF THE DETACHMENT TIP MECHANISM WAS USED, CAUSING THE COIL PROXIMAL CONSTRAINT BALL TO RELEASE FROM THE DDT. ALL PARTS THAT ARE ASSOCIATED WITH THE DETACHMENT TIP MECHANISM WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE SR WIRE WAS LIKELY BROKEN DURING REMOVAL OF THE COIL FROM THE PATIENT WITH THE SNARE DEVICE AND IS NOT ASSOCIATED WITH THE DEVICE ISSUE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE TOP OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA COIL 400 AND PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, WHILE THE COIL WAS BEING FORMED [ADVANCED AND RETRACTED] IT DETACHED PREMATURELY AND HAD TO BE RETRIEVED BY BREAKING OFF THE HUB OF THE PXSLIM MICROCATHETER AND USING A GOOSENECK SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329553 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F30017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention